Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
241 participants
INTERVENTIONAL
2006-03-31
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Accolade® TMZF® Hip Stem
Accolade® TMZF® Hip Stem Study Device
Accolade® TMZF® Hip Stem
Accolade® TMZF® Hip Stem
Interventions
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Accolade® TMZF® Hip Stem
Accolade® TMZF® Hip Stem
Eligibility Criteria
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Inclusion Criteria
2. Patient has primary diagnosis of osteoarthritis (OA).
3. Male and non-pregnant female patients ages 18 to 90.
4. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form.
5. Patient willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
6. Patient capable of undergoing a pre-op central DXA (dual-energy x-ray absorptiometry) scan for a bone mineral density (BMD) reading.
Exclusion Criteria
2. Patient requires a revision surgery of a previously implanted total hip arthroplasty or hip fusion to the affected joint.
3. Patient who is morbidly obese, Body Mass Index (BMI) \> 40.
4. Patient has a neuromuscular or neurosensory deficiency, which limits ability to evaluate the safety and efficacy of the device.
5. Patient has the following diagnosed systemic diseases: Paget's disease, renal osteodystrophy, lupus erythematosus, rheumatoid arthritis, metabolic bone disease and sickle cell anemia.
6. Patient is immunologically suppressed or receiving chronic steroids more than 30 days. Patients receiving oral or IV steroids within one month of surgery.
7. Patient is a prisoner.
18 Years
90 Years
ALL
No
Sponsors
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Stryker Orthopaedics
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Krushell, MD
Role: STUDY_CHAIR
Baystate Medical Center
Carlton Savory, MD
Role: PRINCIPAL_INVESTIGATOR
Hughston Sports Medicine Center
Robert Zann, MD
Role: PRINCIPAL_INVESTIGATOR
Boca Raton Community Hospital
Steven Gausewitz, MD
Role: PRINCIPAL_INVESTIGATOR
Hoag Hospital
R. Scott Oliver, MD
Role: PRINCIPAL_INVESTIGATOR
Jordan Hospital
Mary O'Connor, MD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Anthony Sanchez, MD
Role: PRINCIPAL_INVESTIGATOR
Spartanburg Regional Health Service District, Inc
Mark Visk, MD
Role: PRINCIPAL_INVESTIGATOR
Spartanburg Regional Health Service District, Inc
Steven Teeny, MD
Role: PRINCIPAL_INVESTIGATOR
St. Clare Hospital
Alan Valadie, MD
Role: PRINCIPAL_INVESTIGATOR
Coastal Orthopedics and Sports Medicine
Steven Zelicof, MD
Role: PRINCIPAL_INVESTIGATOR
Sound Shore Medical Center of Westchester
James Bates, MD
Role: PRINCIPAL_INVESTIGATOR
Alvarado Hospital
Locations
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Newport Orthopaedic Institute
Newport Beach, California, United States
Alvarado Ortho Medical Group
San Diego, California, United States
Orthopaedic Surgery Associates
Boynton Beach, Florida, United States
Coastal Orthopaedics
Bradenton, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Hughston Clinic P.A.
Columbus, Georgia, United States
Plymouth Bay Ortho Association
Duxbury, Massachusetts, United States
New England Orthopaedic Surgeons
Springfield, Massachusetts, United States
Specialty Orthopaedics
Harrison, New York, United States
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States
Northwest Orthopaedic Institute
Tacoma, Washington, United States
Countries
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Other Identifiers
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59
Identifier Type: -
Identifier Source: org_study_id
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